FDA Grants Breakthrough Device Status to Quest Diagnostics’ Revolutionary MRD Test

In a significant development for cancer diagnostics, the FDA has granted breakthrough device designation to Quest Diagnostics’ Haystack minimal residual disease (MRD) test. Designed to detect circulating tumor DNA (ctDNA) in stage II colorectal cancer patients, the test represents a potential game-changer in post-surgical adjuvant therapy guidance and cancer recurrence monitoring.

Quest Diagnostics introduced the Haystack MRD test to the market in late 2024 as a clinical laboratory-developed tool, aiming to expand its reach among pharmaceutical companies and oncology professionals. The test’s ability to identify minuscule traces of ctDNA offers a sensitive approach to detecting residual or returning cancer, positioning it as a pivotal asset in cancer management. Having been utilized in numerous clinical trials across North America and Australia, the test is now part of Quest’s expanding oncology testing portfolio. Over 75 cancer and academic centers have embraced this advanced liquid biopsy for clinical use. Additionally, Haystack Oncology has made it available for clinical trials as an investigational device in labs located in Baltimore, Hamburg, and Helsinki, supporting its global reach and applicability.